What is the most important information I should know about buprenorphine and naloxone?
Buprenorphine and naloxone is not for use as a pain medication.
This medicine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
What is buprenorphine and naloxone?
Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.
Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication.
Buprenorphine and naloxone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking buprenorphine and naloxone?
You should not use this medicine if you are allergic to buprenorphine or naloxone (Narcan).
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- any type of breathing problem or lung disease;
- enlarged prostate, urination problems;
- liver or kidney disease;
- abnormal curvature of the spine that affects breathing;
- problems with your gallbladder, adrenal gland, or thyroid;
- a head injury, brain tumor, or seizures; or
- alcoholism, drug addiction, mental illness.
Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
If you use buprenorphine and naloxone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.
Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.
How should I take buprenorphine and naloxone?
Follow all directions on your prescription label. This medicine can slow or stop your breathing. Your doctor may occasionally change your dose. Never use buprenorphine and naloxone in larger amounts, or for longer than prescribed.
This medicine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine and naloxone is against the law.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Use dry hands when handling the tablet or film. Drink a glass of water to moisten your mouth. Place the sublingual tablet or sublingual film under the tongue and allow it to dissolve. Place the buccal film in your mouth against the inside of your cheek and allow it to dissolve. Do not chew or cut a tablet or film, and do not swallow it whole.
If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.
Do not stop using buprenorphine and naloxone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
You will need frequent blood tests to check your liver function.
Wear a medical alert tag or carry an ID card stating that you take this medicine. Any medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using this medicine in case they need to speak for you during an emergency.
Never crush or break a buprenorphine and naloxone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
Store at room temperature away from moisture and heat. Keep this medicine in the foil pouch until ready to use. Discard the empty pouch in a place children and pets cannot get to.
Keep track of your medicine. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine and naloxone overdose can be fatal, especially in a child or other person using the medicine without a prescription.
Overdose symptoms may include extreme drowsiness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, very slow breathing, or coma.
What should I avoid while taking buprenorphine and naloxone?
Do not drink alcohol. Dangerous side effects or death could occur.
This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
What are the possible side effects of buprenorphine and naloxone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once or seek emergency medical attention if you have:
- weak or shallow breathing, feeling like you might pass out;
- confusion, loss of coordination, extreme weakness;
- blurred vision, slurred speech;
-
liver problems --nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
-
opioid withdrawal symptoms --shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
- dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
- withdrawal symptoms;
- tongue pain, redness or numbness inside your mouth;
- nausea, vomiting, constipation;
- headache, back pain;
- fast or pounding heartbeats, increased sweating; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect buprenorphine and naloxone?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
-
other narcotic medications --opioid pain medicine or prescription cough medicine;
-
a sedative like Valium --diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others; or
-
drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.
This list is not complete. Other drugs may interact with buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about buprenorphine and naloxone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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